U.S. patent application number 14/111602 was filed with the patent office on 2014-02-06 for needle assembly for a medical device.
This patent application is currently assigned to SANOFI-AVENTIS DEUTSCHLAND GMBH. The applicant listed for this patent is Turhan Ergel, Michael Jugl. Invention is credited to Turhan Ergel, Michael Jugl.
Application Number | 20140039413 14/111602 |
Document ID | / |
Family ID | 44242912 |
Filed Date | 2014-02-06 |
United States Patent
Application |
20140039413 |
Kind Code |
A1 |
Jugl; Michael ; et
al. |
February 6, 2014 |
NEEDLE ASSEMBLY FOR A MEDICAL DEVICE
Abstract
Described is a needle assembly comprising of a needle hub having
a coupling mechanism adapted to engage corresponding coupling
mechanism of a retainer, and a notch formed in a proximal end of
the needle hub, wherein the notch is adapted to engage a projection
on the retainer.
Inventors: |
Jugl; Michael; (Frankfurt am
Main, DE) ; Ergel; Turhan; (Frankfurt am Main,
DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Jugl; Michael
Ergel; Turhan |
Frankfurt am Main
Frankfurt am Main |
|
DE
DE |
|
|
Assignee: |
SANOFI-AVENTIS DEUTSCHLAND
GMBH
Frankfurt am Main
DE
|
Family ID: |
44242912 |
Appl. No.: |
14/111602 |
Filed: |
April 17, 2012 |
PCT Filed: |
April 17, 2012 |
PCT NO: |
PCT/EP2012/056997 |
371 Date: |
October 14, 2013 |
Current U.S.
Class: |
604/240 |
Current CPC
Class: |
A61M 5/348 20130101;
A61M 5/346 20130101; A61M 5/34 20130101; A61M 2205/582 20130101;
A61M 2205/581 20130101 |
Class at
Publication: |
604/240 |
International
Class: |
A61M 5/34 20060101
A61M005/34 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 20, 2011 |
EP |
11163250.1 |
Claims
1-11. (canceled)
12. A needle assembly comprising: a needle hub having a coupling
mechanism adapted to engage corresponding coupling mechanism of a
retainer; and a notch formed in a proximal end of the needle hub,
wherein the notch is adapted to engage a projection on the
retainer.
13. The needle assembly according to claim 12, wherein a shape of
the projection corresponds to a shape of the notch.
14. The needle assembly according to claims 12, wherein a feedback
is provided when the projection engages the notch.
15. The needle assembly according to claim 14, wherein the feedback
is at least one of a tactile feedback and an audible feedback.
16. The needle assembly according to claim 12, wherein a plurality
of notches are formed in the proximal end of the needle hub.
17. The needle assembly according to claim 12, wherein a plurality
of projections are formed on the retainer.
18. The needle assembly according to claim 17, wherein the
plurality of projections are disposed at regular intervals.
19. The needle assembly according to claim 12 wherein the notch is
an inverted U-shape.
20. The needle assembly according to claim 12 wherein the notch is
triangular.
21. The needle assembly according to claim 12 wherein the notch
includes a surface adapted to prevent movement of the projection in
a first direction.
22. The needle assembly according to claim 12, wherein the retainer
is an injection device.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a U.S. National Phase Application
pursuant to 35 U.S.C. .sctn.371 of International Application No.
PCT/EP2012/056997 filed Apr. 17, 2012, which claims priority to
European Patent Application No. 11163250.1 filed Apr. 20, 2011. The
entire disclosure contents of these applications are herewith
incorporated by reference into the present application.
TECHNICAL FIELD
[0002] The invention relates to a needle assembly for a medical
device. More particularly, the invention relates to a needle
assembly for an injection device.
BACKGROUND
[0003] Conventional needle assemblies adapted to connect a retainer
for a medical ampoule are well known. Typically, the needle
assembly comprises a screw thread that engages a corresponding
screw thread formed on the retainer. However, patients may
over-tighten the needle assembly to the retainer which can lead to
removal problems. Similarly, over-tightening (or attempts to
replace an over-tightened needle assembly) may lead to displacement
of portions of the retainer or mechanisms in the retainer used for
administering a dose of medicament or needle-stick injuries.
[0004] Thus, there is a need for a needle assembly which prevents
the problems associated with over-tightening the needle assembly to
a medical device.
SUMMARY
[0005] It is an object of the present invention to provide an
improved needle assembly suitable for a retainer (e.g., an
injection device) containing a medical ampoule that allows for a
quick, easy and safe fastening and unfastening. It is a further
object of the invention to provide a method of assembling a medical
device that avoids jamming of the assembled parts.
[0006] In an exemplary embodiment, a needle assembly comprises a
needle hub having a coupling mechanism adapted to engage
corresponding coupling mechanism of a retainer, and a notch formed
in a proximal end of the needle hub. The notch is adapted to engage
a projection on the retainer. A shape of the projection corresponds
to a shape of the notch.
[0007] In an exemplary embodiment, a feedback is provided when the
projection engages the notch. The feedback may be at least one of a
tactile feedback and an audible feedback.
[0008] In an exemplary embodiment, a plurality of notches may be
formed in the proximal end of the needle hub, and a plurality of
projections may be formed on the retainer. The plurality of
projections may be disposed at regular intervals.
[0009] The notch may be an inverted U-shape or triangular.
[0010] In an exemplary embodiment, the notch includes a surface
adapted to prevent movement of the projection in a first
direction.
[0011] The exemplary embodiments of the needle assembly according
to the present invention are preferably used in combination with
retainers that may be used as components of injection devices,
including but not limited to, pen-type injection devices, syringes,
cartridge syringes, safety syringes, auto-injectors, etc. Further,
it is foreseen that the needle assembly according to the present
invention may be utilized with catheter and/or infusion
assemblies.
[0012] Further scope of applicability of the present invention will
become apparent from the detailed description given hereinafter.
However, it should be understood that the detailed description and
specific examples, while indicating preferred embodiments of the
invention, are given by way of illustration only, since various
changes and modifications within the spirit and scope of the
invention will become apparent to those skilled in the art from
this detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The present invention will become more fully understood from
the detailed description given hereinbelow and the accompanying
drawings which are given by way of illustration only, and thus, are
not limitive of the present invention, and wherein:
[0014] FIG. 1 shows a sectional view of a prior art needle
assembly;
[0015] FIG. 2 shows an isometric view of a needle assembly
according to an exemplary embodiment of the invention;
[0016] FIG. 3 shows an isometric view of a needle assembly
according to an exemplary embodiment of the invention;
[0017] FIGS. 4A and 4B show isometric views of a needle assembly
according to an exemplary embodiment of the invention;
[0018] Corresponding parts are marked with the same reference
symbols in all figures.
DETAILED DESCRIPTION
[0019] FIG. 1 shows a conventional needle assembly A for a medical
device D according to the prior art. The conventional needle
assembly A consists of a needle hub 1 with a double-sided needle
1.1 and a retainer 2 for housing a medical ampoule 3 containing a
medicament M. A distal opening of the medical ampoule 3 is sealed
by a septum 3.1. The needle 1.1 has a distal tip for penetrating
the skin of a patient and a pointed proximal tip 1.1.1 for piercing
the septum 3.1 when the needle hub 1 is mounted to the retainer 2
so as to establish fluid communication of the needle 1.1 with the
interior of the medical ampoule 3.
[0020] Corresponding screw threads are formed on an inner surface
of the needle hub 1 and an outer surface of a distal section of the
retainer 2 so that the needle hub 1 may be engaged with the
retainer 2. When the needle hub 1 is properly engaged with the
retainer 2, further rotation of the needle hub 1 relative to the
retainer 2 is blocked by (i) a distal surface 2.1 of the retainer 2
abutting against a distal surface 1.2 of the needle hub 1 and (ii)
a proximal end of the needle hub 1 abutting against a shoulder 2.2
of the retainer 2. However, the user may continue attempting to
rotate the needle hub 1 relative to the retainer 2 which can result
in difficulty removing the needle hub 1, injury when removing the
needle hub 1, or displacement of other components of the retainer 2
(or mechanisms therein for dispensing the medicament M).
[0021] FIG. 2 shows an isometric view of an exemplary embodiment of
a needle assembly A according to the present invention. The needle
assembly A comprises a needle hub 1 with a coupling mechanism
(e.g., screw threads, a bayonet fitting, a frictional surface,
etc.) formed on an inner surface thereof. The coupling mechanism on
the needle hub 1 is adapted to engage a corresponding coupling
mechanism (e.g., screw threads, a bayonet fitting, a frictional
surface, etc.) formed on an outer surface of a distal end of a
retainer 2 for a medical ampoule 3. In an exemplary embodiment, the
needle hub 1 may be cylindrical and include a textured surface on
an outer surface thereof to facilitate the user's grip when
coupling to and removing from the retainer 2. However, those of
skill in the art will understand that the needle hub 1 may be of
any shape and size which will suitably accommodate a distal end of
the retainer 2. The retainer 2 may be a part of a pen-type
injection device, a syringe, a cartridge syringe, a safety syringe,
an auto-injector, a catheter and/or any other injection device
and/or infusion assembly.
[0022] The needle assembly A further includes a needle 1.1 coupled
to the needle hub 1. In the exemplary embodiment, the needle 1.1
includes a distal tip for piercing the skin and a proximal tip for
piercing a septum of the medical ampoule 3.
[0023] In an exemplary embodiment, the needle hub 1 includes at
least one notch 6 formed in its proximal end. For example, as shown
in the exemplary embodiment in FIG. 2, the notch 6 is formed as an
inverse U-shaped recess in a circumference of the proximal end of
the needle hub 1. While the exemplary embodiment shown in FIG. 2
depicts the needle hub 1 having one notch 6, those of skill in the
art will understand that the needle hub 1 may include a plurality
of notches 6, as shown in the exemplary embodiment in FIG. 3. The
plurality of notches 6 may be spaced at regular intervals around a
circumference of the distal end of the retainer 2.
[0024] The notch 6 may be sized and shaped to engage a projection
5. In an exemplary embodiment, the projection 5 may be formed on an
outer surface of a distal end of the retainer 2, proximal to the
screw threads formed on the retainer 2. For example, the projection
5 may be formed as a protrusion on a shoulder 2.2 of the retainer 2
and extend a predetermined distance in the distal direction. In an
embodiment in which there is a plurality of projections 5, the
projections 5 may extend the same or different distances in the
distal direction. The projection 5 may include a proximal end which
abuts the shoulder 2.2 and a distal end which is sized and shaped
to engage the notch 6. For example, in the exemplary embodiment in
which the notch 6 is an inverted U-shaped recess, the projection 5
may have an inverted U-shaped distal end. The projection 5 may
extend a predetermined distance distally along a length of the
outer surface of the distal end of the retainer 2. Preferably, the
shapes of the projection 5 and 6 correspond closely such that use
of the medical device D during an injection does not cause a
projection 5 to rotate past a corresponding notch 6.
[0025] In another exemplary embodiment, the notch 6 may be formed
on the shoulder 2.2 of the retainer 2, and the projection 5 may be
formed on the proximal end of the needle hub 1. In another
exemplary embodiment, the projection 5 may be formed on a coupling
which attaches to the retainer 2. That is, the coupling may be
attached to a distal end of an otherwise conventional medical
device D to allow the medical device D to accommodate a needle hub
1 according to the present invention.
[0026] When the needle assembly A is attached to the retainer 2,
screw threads on the needle hub 1 may engage corresponding screw
threads on the retainer 2. Prior to the screw threads and the
corresponding screw threads being substantially fully engaged, the
user may receive a first feedback (e.g., a resistance) which
indicates that a distal portion of the projection 5 is abutting a
proximal portion of the needle hub 1. As the needle hub 1 is
further rotated, a second feedback (e.g., sudden release of
resistance and/or an audible sound) may be provided to the user
when the projection 5 engages the notch 6. The second feedback may
indicate to the user that the needle hub 1 has properly engaged the
retainer 2 and that further rotation is neither necessary nor
desirable.
[0027] In another exemplary embodiment, the notch 6 may be formed
such that it prevents rotation of the needle hub 1 in a tightening
direction after the needle hub 1 has been properly engaged by the
retainer 2. For example, the notch 6 may be a triangular recess
which has a first leg sloped relative to the proximal end of the
needle hub 1 and a second leg perpendicular relative to the
proximal end of the needle hub 1. In this exemplary embodiment,
when the projection 5 engages the notch 6, the projection 5 may
abut the second leg, preventing further rotation of the needle hub
1 relative to the retainer 1 in a first, tightening direction.
However, the first leg would not prevent rotation in a second,
loosening direction, allowing for removal of the needle hub 1.
[0028] When the projection 5 protrudes into the notch 6, the needle
hub 1 may be properly secured to the retainer 2. In an exemplary
embodiment, the projection 5 and the notch 6 are dimensioned so as
to define an axial gap between the first and second distal surfaces
2.1, 1.2 when the needle hub 1 is screwed all the way in and the
relative rotation of the needle hub 1 and the retainer 2, at least
in a direction which could lead to further tightening, is blocked.
Thus, the first and second distal surfaces 2.1, 1.2 may be spaced
away from each other when the needle hub 1 is secured onto the
retainer 2 and do not frictionally engage each other so as to
reduce the area of the frictional surface between the needle hub 1
and the retainer 2. Thus, the risk of the needle hub 1 getting
jammed to the retainer 2 is minimized.
[0029] The audible and/or tactile feedback may additionally
indicate that the proximal tip 1.1.1 of the needle 1.1 has pierced
the septum 3.1 on the distal opening of the medical ampoule 3.
Thus, the needle 1.1 is in fluid communication with the interior of
the medical ampoule 3 containing the dose of the medicament M and
the medical device D is ready to be used for an injection.
[0030] In an exemplary embodiment, a window 2.3 may be formed in a
portion of the retainer 2 proximal to the threaded surface, and the
medical ampoule 3 is preferably made from a transparent material.
Thus, the amount of the medicament M left in the medical ampoule 3
may be seen through the window 2.3.
[0031] FIG. 3 shows an isometric view of another exemplary
embodiment of the needle assembly A according to the present
invention. In this exemplary embodiment, a plurality of projections
5 is formed on the shoulder 2.2 of the retainer 2, and a plurality
of notches 6 are formed on a proximal end of the needle hub 1.
Those of skill in the art will understand that design variations
may be utilized, e.g., a needle hub 1 with a single notch 6 or the
plurality of notches may be utilized with a retainer with a single
projection 5 or the plurality of projections 5.
[0032] FIGS. 4A and 4B show isometric views of an exemplary
embodiment of the needle assembly A according to the present
invention. A first set of projections 5 is formed on the shoulder
2.2 of the retainer 2. A second set of projections is formed on a
proximal end of the needle hub 1 and consecutive projections are
separated by notches 6. When the needle hub 1 is rotated relative
to the retainer 2, a first feedback (e.g., tactile and/or audible)
is provided when one of the projections 5 of the first plurality of
projections engages a notch 6 on the needle hub 1 and abuts one of
the second plurality of projections on the needle hub 1. When the
first feedback is provided, the user receives an indication that
the needle hub 1 is properly secured to the retainer 2 and that
further tightening is unnecessary.
[0033] Those of skill in the art will understand that modifications
(additions and/or removals) of various components of the
apparatuses, methods and/or systems and embodiments described
herein may be made without departing from the full scope and spirit
of the present invention, which encompass such modifications and
any and all equivalents thereof.
* * * * *